利用技术进行食物过敏症状自我管理（FASST）的移动健康干预措施，以改善新诊断食物过敏儿童的照料者的心理社会状况：一项试点随机对照试验方案

Food Allergy Symptom Self-Management With Technology (FASST) mHealth Intervention to Address Psychosocial Outcomes in Caregivers of Children With Newly Diagnosed Food Allergy: Protocol for a Pilot Randomized Controlled Trial.

作者信息

Broome Brantlee, Madisetti Mohan, Prentice Margaret, Williams Kelli Wong, Kelechi Teresa

机构信息

College of Nursing, Medical University of South Carolina, Charleston, SC, United States.

College of Medicine, Medical University of South Carolina, Charleston, SC, United States.

出版信息

JMIR Res Protoc. 2021 Mar 3;10(3):e25805. doi: 10.2196/25805.

DOI:10.2196/25805

PMID:33656448

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7970224/

Abstract

BACKGROUND

Approximately 2.4 million children in the United States suffer from food-induced anaphylaxis, a condition that is annually responsible for over 200 deaths and 200,000 emergency room visits. As a result, caregivers of children newly diagnosed with severe and life-threatening food allergic reactions experience clinically significant symptoms of psychological distress, including fatigue, anxiety, depressed mood, social isolation, and substantially reduced quality of life. Despite this recognition, there is a lack of caregiver-centered self-management interventions to address these concerns.

OBJECTIVE

In this protocol, we propose to develop and conduct feasibility testing of a technology-enhanced, self-management, mobile health, smartphone app intervention called Food Allergy Symptom Self-Management with Technology for Caregivers (FASST) designed to meet the psychosocial health needs of caregivers of children with a new diagnosis of food allergy.

METHODS

This pilot study uses qualitative work (Phase I) to inform a 4-week longitudinal randomized controlled trial (Phase II). In Phase I, 10 caregivers of children (≤18 years old) with established food allergy (≥1 year from diagnosis) will participate in semistructured interviews to inform the development of the FASST app. In Phase II, 30 caregivers of children (≤18 years old) with a newly diagnosed food allergy (≤90 days from diagnosis) will be randomized 2:1 to receive the FASST intervention (n=20) or control condition (basic app with educational resources; n=10). Process measures include feasibility, caregiver acceptability, adherence, and satisfaction. Outcome measures include caregiver fatigue, anxiety, depression, sleep, self-efficacy, and quality of life measured at baseline, week 4, and 3 months post study completion.

RESULTS

Phase I study activities have been completed, and Phase II participant enrollment into the randomized controlled trial is expected to commence in 2021.

CONCLUSIONS

With limited readily available resources at their disposal, the results from this study have the potential to provide caregivers of children with a newly diagnosed food allergy a tool to help them self-manage and mitigate negative psychosocial factors during a critical time period in the caregiving/condition trajectory.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier NCT04512924: https://clinicaltrials.gov/ct2/show/NCT04512924.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25805.

摘要

背景

美国约有240万儿童患有食物诱发的过敏反应，这种情况每年导致200多人死亡，20万人次急诊就诊。因此，新诊断出患有严重且危及生命的食物过敏反应的儿童的照料者会出现具有临床意义的心理困扰症状，包括疲劳、焦虑、情绪低落、社交隔离以及生活质量大幅下降。尽管人们已经认识到这一点，但缺乏以照料者为中心的自我管理干预措施来解决这些问题。

目的

在本方案中，我们提议开发并进行一项可行性测试，该测试针对一种名为“食物过敏症状自我管理技术照料者应用程序（FASST）”的技术增强型、自我管理、移动健康、智能手机应用程序干预措施，旨在满足新诊断出食物过敏儿童的照料者的心理社会健康需求。

方法

这项试点研究采用定性研究（第一阶段）为为期4周的纵向随机对照试验（第二阶段）提供信息。在第一阶段，10名患有确诊食物过敏（确诊时间≥1年）的18岁及以下儿童的照料者将参与半结构化访谈，以为FASST应用程序的开发提供信息。在第二阶段，30名新诊断出食物过敏（确诊时间≤90天）的18岁及以下儿童的照料者将按2:1随机分组，接受FASST干预（n = 20）或对照条件（带有教育资源的基础应用程序；n = 10）。过程指标包括可行性、照料者可接受性、依从性和满意度。结果指标包括在基线、第4周和研究完成后3个月时测量的照料者疲劳、焦虑、抑郁、睡眠、自我效能感和生活质量。